BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room

    Recall: Z-0168-2017 · Reported October 26, 2016

    Enforcement

    Recall Number
    Z-0168-2017
    Event ID
    71968
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Windstone Medical Packaging, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 26, 2016
    Initiation Date
    April 22, 2015
    Classification Date
    October 20, 2016
    Termination Date
    October 25, 2016
    Address
    1602 4th Ave N, N/A, Billings, MT, 59101-1521, United States

    Description

    Custom Venous Kit, TVS4024(C convenience custom kits used for general surgery in hospital operating room

    Reason

    The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

    Code Info

    Lot Numbers Expiration Dates 57411 5/13/2015 58475 5/14/2015 57820 5/17/2015 60799 8/3/2015 62975 11/14/2015 63103 11/14/2015 62235 11/15/2015 62675 11/25/2015 65935 11/27/2015 60995 11/29/2015 63104 12/14/2015 64487 1/5/2016 63521 1/29/2016 67570 4/30/2016 68694 7/11/2016 69235 7/14/2016 68935 7/18/2016 67788 7/30/2016 70949 9/19/2016 76072 11/2/2016 80515 11/2/2016 74746 11/9/2016 76638 11/25/2016 73892 11/26/2016 75428 11/28/2016 79295 11/30/2016 71620 12/12/2016 70720 1/4/2017 75219 5/31/2017 77663 6/19/2017 78672 8/22/2017

    Distribution

    Nationwide Distribution to California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia, and Wyoming.

    Quantity

    1584 kits